Antiproteinuric Effect of Valsartan and Lisinopril

Phase 4

Completed

• Conditions: Hypertension; Diabetic Nephropathy

• Registration Number: NCT00171574
• Lead Sponsor: Novartis

Brief Summary

Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up.

Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.

Design: Multicentric, randomized, double blind, parallel group, active controlled.

Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Male or female outpatients aged 18-70 years,
2. Chronic nephropathy, as defined by a serum creatinine concentration of > 3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.
3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).
5. Written informed consent to participate in the study prior to any study procedures.

Exclusion Criteria

• Immediate need for renal replacement therapy.
• Treatment resistant oedema.
• Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs.
• Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.
• Renovascular hypertension
• Malignant hypertension
• MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.
• Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.
• A serum creatinine concentration >265 ümol/L

Other protocol-defined exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in urine protein excretion after 20 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in a laboratory measure of kidney function after 20 weeks
Change from baseline in systolic blood pressure after 20 weeks
Change from baseline in diastolic blood pressure after 20 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland